Care Delivery for Patients with Leiomyomas: Failures, Real-Life Experiences, Analysis of Barriers, and Proposed Restorative Remedies

In this narrative review, we describe historical and contemporary influences that prevent patients with fibroids from getting appropriate medical care. Using patient stories as examples, we highlight how misogyny on all levels hurts patients and prevents medical teams from doing their best. Importantly, inequity and disparities result in massive gaps in care delivery. We suggest that we, as gynecologists and surgeons, must join public discourse on this topic to highlight the inadequacies of care delivery and the reasons behind it, suggest potential solutions, and join patients and communities in formulating and implementing remedies.

In the Trenches ''I first met Mrs. A, a frightened 49-year-old woman, when her son brought her to the emergency room after a syncopal episode. She was found to be in septic shock from an infected uterus after undergoing a uterine fibroid embolization (UFE) one month prior. I took to her the operating room to do an emergent abdominal hysterectomy where she was found to have a 32-weeksized uterus with several large pedunculated fibroids, one of which was an infected necrotic 10-centimeter pedunculated myoma with purulent matter leaking into the abdomen. After surgery, she spent several days in the intensive care unit and was discharged from the hospital a week later. Her recovery was long, but she was able to recover and return to her activities of daily living and her job as a manager in a bank.
Mrs. A was under the care of one of the community gynecologists. She was trying to avoid surgery. Although her gynecologist (private practice, mostly office setting, rare open hysterectomies, and no minimally invasive gynecologic surgery [MIGS] experience) counseled her that she was not a good candidate for UFE because of the large fibroid burden, high failure rate, and greater risk, the patient self-referred to a local 'fibroid center' and underwent a UFE. After her procedure, she started to develop worsening pain and malaise. She called her interventional radiologist several times to report her symptoms. He reassured her that this was expected during her recovery and did not evaluate her.
I called the interventional radiologist. While concerned with her clinical course, he did not even consider the appropriateness of UFE in her case. Several months later, I heard from Mrs. A's attorney. The patient was seeking restorative justice, wanted an acknowledgment of what happened to her, and wanted to ensure that the same did not happen to other women. Her attorney declined to take her case due to a 'low anticipated payout.' Since this interventional radiologist was in private practice, there was no 'quality and safety' entity to which to report him.
I discussed the case with my hospital's risk management department, but they had no recommendations other than reporting him to the state department of health and were reticent to become involved as none of our institution's physicians were involved in the decision to perform UFE. From the patient's perspective, none of these attempts led to anything meaningful for her in the way of justice.'' This narrative by one of the authors (V.T.L.) of Mrs. A's case is not in isolation. We often share our ''war stories,'' such as postmenopausal women with postmenopausal bleeding without endometrial sampling, women planning to undergo assisted reproductive technology (ART) treatments, and young women with very high fibroid burden desiring fertility getting UFE. On the contrary, in many of our surgical communities, we have wonderful interventional radiology (IR) colleagues who work collaboratively with us. Together, we build service lines, staff joint IR/MIGS clinics, review difficult cases in treatment planning conferences, and engage in quality improvement initiatives to make sure patients get access to the information they need to make informed decisions. Our IR colleagues save lives in gynecologic emergencies where surgery is not the best option.
Just as we have concerns about inadequate care by interventional radiologists and their incentive and bias due to favorable reimbursement in an outpatient setting, we are equally disappointed with gynecologic surgeons who do not meet the current standard of care. Examples of failure to meet gynecologic surgical standards of care for leiomyomas include the following: choosing the open surgery route while the majority of hysterectomies and myomectomies can be done via the minimally invasive surgery (MIS) route, unindicated surgery such as removing asymptomatic and small subserosal fibroids because those surgeries are easy, and failing to remove fibroids in more difficult locations. This, however, is not surprising given that Current Procedural Terminology codes do not incentivize the MIS approach, and are the same regardless of case complexity, while high-complexity MIS cases involve more work and risk.
Although the MIS approach is feasible in more than 90% of cases, many surgeons still operate through open incisions because of a lack of training and do not refer patients to those who have this expertise. 1 Gynecologic surgeons also may advertise directly to patients or avoid caring for complications or sequelae of procedures they perform by seeking privileges in different hospitals.
Another aggravating gap in care that gynecologic surgeons often deal with when seeing patients referred for fibroid surgery is the lack of discussion of nonsurgical alternatives by referring providers who tell patients surgery is ''the only option,'' or being told that they are not candidates for surgery without more indepth consideration as to why and without seeing the big picture and nuances specific to each patient. Being informed about how UFE works and how it applies to them often brings enormous relief for patients, regardless of the final decision about the treatment they make. For every case of Mrs. A, we can come up with many stories of fibroid mismanagement in the gynecologic community.
Disparities and inequality amplify all of those gaps. Patients of color and minorized and marginalized people suffer from higher disease burdens and have less access to high-quality medical and surgical care. [2][3][4][5] Those are examples of what goes wrong with the delivery of care in all aspects of medicine, not just fibroids, gynecology, and surgery.
While the topic of why patients are not getting good care regardless of the person, disease, and specialty is an enormously complicated one, sweeping it under the rug because ''it is complicated,'' ''too broken to fix,'' and ''impossible to get right'' only worsens the extent of moral injury that results in clinicians' posttraumatic stress disorder and burnout. We, gynecologists and surgeons, need to own our problems and get over our tendency to bear the burden of not being able to do our best because of the societal and ''system's'' problems. We need to get our narrative out to the public. By doing that, we could find common ground, connect with each other and many advocacy entities, and convey meaning and purpose.
Our professional struggles and experiences, if heard by those around us, can unify us and help us act, even if this action does not result in an immediate meaningful change. While health care professionals can have this dialogue on their terms on social media, online blogs, lay publications, and sociology realms, these conversations are not commonplace in academic discourse in specialty journals. 1,6 The objective of this article is to dissect problems in the delivery of care to women from the perspective of MIG surgeons using UFE as an example, point to deep-rooted causes of those problems, and suggest potential solutions and future directions that individuals and organizations can take to address them.
Historical perspective, unmet need, devaluation of women's health, and systemic discrimination When UFE emerged as a therapeutic option for fibroids in the 1990s, comparison with surgery became an important issue. At the time, there was no standardized way to assess outcomes from a patient's perspective. Unfortunately, common gynecologic conditions, such as fibroids and endometriosis have a major negative impact on the quality of life of millions of women and could lead to serious morbidity, did not have standardized measurement tools. Without such tools, quality research of treatment options was not possible, and this continues to be problematic today. 7 Work by Carlson and colleagues focused on generic measures, but tools that assessed patients' perspectives did not exist. [8][9][10] As a result, when Spies and his IR team started working on measuring UFE outcomes, they felt that they needed to create their own qualityof-life questionnaire for the public domain because of the lack of outcome assessment tools from the patient's perspective in the gynecology literature. 11 Spies' work resulted in UFS-QOL. As an interventional radiologist, Spies was revolutionary in advocating for incorporating patients' take on their treatment. He worked with a group of pharmacodynamic experts funded by an IR research foundation and they created the questionnaire that is now the current standard for assessing outcomes from all fibroid interventions (pers. comm.).
This historical perspective demonstrates a fundamental lack of focus on what is important to women that has persisted in medicine for centuries. Unfortunately, this thinking is still ingrained in our culture. This systemic and long-standing devaluation of women, misogyny, and sexism explains why patients and patient advocacy groups keep asking us ''How can this be that we are still not listening to women?'' Women are still being told that painful and heavy periods are ''normal'' and they just ''need to deal with it.'' Diagnosis of endometriosis, for example, is thought to be delayed by 4-11 years. 12 Likewise, we think that a large proportion of women with symptomatic fibroids are delayed in getting care or are not able to access it at all, although that has not been documented as accurately for this condition. 13,14 Unfortunately, this leads not only to the undertreatment of these common conditions but also to the lack of resource allocation for research on women's health.

Direct restorative remedy #1: go public
Acknowledge past and current discrimination in women's health publicly by bringing patients' and clinicians'stories of how the medical system and our society ignore common medical conditions such as fibroids. While social media platforms have become one way to draw attention to the topic and for clinicians and patients to be heard, we think that professional societies and mainstream medical journals need to create truth and reconsolidation entities. This will create spaces necessary to have these conversations in a wide array of settings and will deliver this information to the public. It will also allow clinicians to partner with patients, community, and equity advocacy groups to build effective medical teams and diversify leadership entities.

The Evidence: Knowns and Unknowns
Lack of an integrated approach and meaningful patient-centered shared decision-making Let us take a closer look at the evolution of UFE efficacy data. Excitement about UFE started in 1995 when Ravina et al. published the first case series of UFE for the management of fibroids, 15 followed by a series of publications from the Fibroid Registry For Outcomes Data (FIBROID). [16][17][18] The FIBROID was created in 1999 and prospectively enrolled more than 3000 patients. Broad support for it in the IR community reflects the dedication many interventional radiologists have to advance patient care and understanding of outcomes. One of the last landmark publications from this registry noted a lasting symptomatic relief after UFE but also found the risk of hysterectomy, myomectomy, and repeat UFE to be 9.79%, 2.82%, and 1.83%, respectively, 3 years after the procedure-significant long-term failure rates that are not consistently addressed in day-to-day clinical conversations. 18 The HOPEFUL study, a multicenter retrospective cohort study from the United Kingdom, followed the steps of the FIBROID registry and reported on outcomes and efficacy in a minimum of 2 years of follow-up (972 hysterectomies and 762 UFE cases). 19 Fewer serious complications were noted in the UFE group with more women reporting symptomatic relief, and more women stating that they would recommend their treatment to a friend. Up to 23% of women in the UFE group received more than one treatment, and 11.2% had a hysterectomy. In younger women with a higher risk of recurrence, UFE was not cost-effective.
The EMMY study (The Uterine Artery Embolization in the Treatment of Symptomatic Uterine Fibroids Tumors-EMbolization vs. HysterectoMY) examined long-term, 10-year outcomes. 20 This European randomized trial demonstrated that of 156 patients in the original cohort, 84% reported similar patient satisfaction rates and quality-of-life metrics in both UFE and hysterectomy groups. However, 35% (28 out of 81 patients) had hysterectomies for recurrence after UFE, in addition to other surgical reinterventions. 20 Similar outcomes are noted in IR literature. 21 While these data are not perfect, we can surely come up with a way to convey it along with the limitations and context to our patients. One may ask then, why then when we ask patients why embolization failed, what their recollection was of what they were told about failure risk before the procedure, responses range from ''nothing'' to ''I was told I might need to do it again.'' Similarly, the same could be said about the patient's recall of surgical risk discussed at the preoperative visit. The subject matter of conveying medical information that patients need to make decisions, especially since we know that patient recall is minimal long term even after extensive counseling for highstake procedures is complex. 22 While there have been many articles and teaching aids written on UFE and fibroid management, what is lacking are granular implementation pathways on how to convey this information to patients.
Just like Basic Cardiac Life Support certification is mandated by hospitals, the step 3 clinical skills examination and Fundamentals of Laparoscopic Surgery examination are mandatory to become board certified, postpartum hemorrhage team training is required by the Joint Commission to occur on labor and delivery units, and surgical time-outs are videotaped by hospitals to assure compliance with safety checklists-same can be done with any other clinical activity. Many medical schools and residencies, frustrated with the Accreditation Council for Graduate Medical Education milestones (which set learning agenda for doctors in training) that lack objective practical nuance needed for learning assessment, and are ridden with bias in how they are implemented, are turning to entrustable patient activities, along the lines of what is being used in Europe for competency-based certification and credentialing.
Competency in shared decision-making and the tools needed to accomplish it can also be mandated. This would require a major culture change, but we have the tools to accomplish it if desired.

Direct restorative remedy #2: fix information sharing and communication processes
Acknowledge that many patients are not getting adequate information during counseling, are not given the information they need to make decisions, and are not supported in their decision-making. Invest in national ''patient-centered education'' infrastructure. Make it mandatory for the federal government to invest in professional societies, hospitals, communities, patient advocacy groups, and individual practitioners to create and implement high-quality decision aids, tools, and ways of relaying information that would help patients understand treatments and how those treatments apply to them. Encourage health professionals to embrace a growth mindset, advocate for clinical competency assessment, and monitor clinician adherence.
Efficacy and safety of UFE, comparisons with surgical options, and failure of research infrastructure to deliver meaningful information to clinicians and patients While long-term surgical retreatment rates for recurrence after UFE must be shared with patients who are not interested in fertility or to whom uterine conservation is not a priority, it is worth pointing out that the decision for surgery versus UFE is more nuanced than just deciding to have an operation. While hysterectomy results in definitive management, it does not make sense to compare hysterectomy outcomes with UFE in terms of long-term relief as UFE will always have a retreatment risk. Most patients are deciding if they want to ''get it over with once and for all'' and have a hysterectomy or take a chance that UFE would work if properly selected with the main goal of avoiding surgery.
A meaningful comparison would be to look at surgical retreatment rates after UFE versus myomectomy for those patients concerned with keeping their uterus for reasons other than fertility. Here we need to consider surgical morbidity after a myomectomy (especially if not done minimally invasively). While several publications show similar retreatment rates in the long term, 23-25 the recent multicenter study from the United Kingdom, the FEMME trial (A Randomized Trial of Treating Fibroids with Either Embolization of Myomectomy to Measure the Effect on Quality of Life Among Women Wishing to Avoid Hysterectomy) examined outcomes of 254 women. While the study was not able to recruit the planned number of patients after 2 years, both groups improved significantly, but health-related quality-of-life scores were minimally higher in the myomectomy group, complications were the same in both groups, and more surgical reinterventions occurred in the UFE group. The myomectomy route was not reported or analyzed.
Regarding uterine conservation, unfortunately, published data on repeat myomectomies are not granular enough to be useful clinically in terms of surgical morbidity in primary and repeat myomectomies and reproductive outcomes. We have encountered patients who had myomectomies before ART therapies such as in vitro fertilization (IVF) to maximize implantation rates but ended up with failed embryo transfers despite having favorable prognostic factors. At times, fluid is seen in the cavity, and defects are noted to be similar to a cesarean section niche, suggestive of uterine factor. Would these patients do better with UFE if they had frozen euploid embryos from IVF treatments and just needed fibroid shrinkage of small fibroid burden, especially if they had a prior myomectomy? We do not know the answer to this and many related nuanced questions.
Deeper questions remain unanswered concerning long-term outcomes and patient selection. As UFE became more common, several studies comparing UFE and surgery were conducted by Refs. 26-33 A 2014 Cochrane systematic review included data from 7 randomized controlled trials (RCTs) with 793 women. 34 Based on limited evidence, authors concluded that there was no difference in satisfaction rates between the surgery and UFE groups for up to a 5-year followup, but UFE was associated with a higher rate of minor complications and a higher risk of subsequent operation, quoted as15-32% within 2 years. 34 Systematic reviews and meta-analyses continue to be published based on smaller limited studies. [34][35][36][37][38][39] A robust comparative effectiveness review on the management of fibroids was published in 2017 and funded by the Agency for Healthcare Research and Quality. The authors firmly stated that ''there is insufficient evidence for women to choose one intervention over another based on individual characteristics'' due to a lack of power to examine subgroups for outcomes. 37 Another impressive research effort currently in progress is Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF), a prospective multicenter fibroid registry in the United States. 40 It is the largest federally funded outcome study ever, planned to enroll 10,000 patients who had procedures to treat fibroids. In contrast to prior simplistic and limited comparative studies, the authors planned to report on the efficacy of all routes of hysterectomy and myomectomy, endometrial ablation, radiofrequency ablation (RFA), UFE, magnetic resonance imaging-guided focused ultrasound (MRgFUS), progestin-releasing intrauterine device and to disseminate it to stakeholders. 40 Currently, more than 3000 women are enrolled, and the plan is to follow the cohort over 2 years. 40 Unfortunately, even this massive undertaking ran into logistical problems of research infrastructure, volume, and ability to get a representative sample, and, as a result, the number of women getting UFE was relatively small (pers. comm.).
Several articles describing women's experience with treatments, and comparisons in quality-of-life improvements between myomectomy and hysterectomy, including route, have recently been published, but long-term comparisons of surgery with UFE are not yet in print. 41,42 We hope to see the publications from this landmark study shortly and to learn more about the difficulties of trying to do outcome-based research on a large scale in the United States in women's health, which lacks data collection and tracking researchers need to understand complex conditions affecting many.
Finally, while patient satisfaction and quality-of-life measures are very important, other parameters need to be captured such as uterine volume and fibroid burden (number, size, location). Given the inclusion/exclusion criteria in UFE studies and the variability of fibroids and the symptoms they cause, even randomized control trial data may be difficult to apply to individual patients in the current format.
UFE results in ischemic degeneration from selective catheterization of uterine arteries under fluoroscopic guidance via injection of embolic agents. Immediate procedural risks such as groin hematomas, allergic reactions, arterial thrombosis, and pseudoaneurysms are deemed to be low ( < 5%). 43 However, other sequelae such as nonselective embolization have been associated with more serious yet still rare events such as dyspareunia and sexual dysfunction, 44 vaginal, buttock, and subcutaneous tissue necrosis, and chronic pain. 3 Given the steady increase in UFE procedures performed over the last two decades, outcome data are limited to registries and population-level studies and administrative databases similar to those that exist to describe surgical outcomes for fibroid surgeries 38,45 do not exist for UFE. As a result, counseling patients based on outcomes with limited comprehensive and reliable sources of evidence is challenging. For example, the largest study to date was published in 2002, which included a single-center registry consisting of 400 patients who were prospectively followed for a minimum of 3 months after UFE. 46 The overall complication rate was 8.5%, of which 1.25% was considered to be serious complications and included emergent hysterectomy, undetected leiomyosarcoma, pulmonary emboli, arterial thrombosis, leiomyoma passage associated with infection, and hemorrhage, and readmissions, with overall morbidity of 5%. 46 While this study provides a snapshot of complication trends in 2002 for those 400 patients, limited reporting of UFE outcomes limits our ability to understand more contemporary trends. Another important factor to consider is the type of complications that occurs with fibroids based on size, number, and location. While we might be able to discuss specific RCTs with carefully selected patients, applying those findings in the ''real world'' is challenging as fibroids have such vast diversity in character and clinical presentation.
Published literature on complications to date is limited to case series 47,48 and Manufacturer and User Facility Device Experience database reports, all of which lack a denominator, as well as meta-analyses that have their inherent limitations. 49 While we inform patients about expected postprocedural pain and postembolization syndrome, counseling may not always include a discussion of prolonged vaginal discharge in up to 20% of patients, 17 failure to complete procedure bilaterally reported as high as 5%, 50 and myoma expulsion that ranges from 1.7% to 50%. 51 Some of these complications require surgical intervention and may occur months to years following the procedure. 51 Reported serious events also include perforated pyomyomas, pelvic abscesses, hematometra, fistulas, bowel obstruction, bowel perforation, uterine necrosis, uterine rupture, placenta increta, sepsis, pulmonary emboli, myocardial infarction, emergency surgery, and death. 49,[52][53][54][55][56][57][58] Of course, these are exceedingly rare and it is not possible to list all complications for procedural inter-ventions, and serious complications are well-established risks of major surgery. 59,60 Adequate counseling must also include a discussion comparing complications of UFE with those of alternative treatment options. Here, too, we lack the data we need to have meaningful discussions. Numerous studies that have examined this topic are outdated as they largely include open surgery for hysterectomy and myomectomy procedures. In an era where most benign gynecologic surgeries have shifted from open to MIGS routes, it is important to consider the changing national and local surgical landscape when counseling patients. In surgical centers where open surgery rates are low, high-volume surgeons are trained in MIS, and enhanced recovery protocols are in place, risk-benefit analysis of surgery compared with UFE is likely to differ from prior comparative studies with high open surgery rates. 30 Just like UFE outcomes improve as procedural details were finessed over the first decade after its introduction, the formula for risk calculation has changed for surgery as well, but it is not reflected in the current literature, thus limiting providers in their efforts to perform the most appropriate informed counseling and consent when discussing appropriate treatment modalities for symptomatic fibroids.
Deficiencies in outcomes research are not unique to UFE. Surgical outcomes are in the same boat. While many of us keep our own outcome data to monitor our surgical performance, 1 very few MIGS divisions who can afford an outcome nurse do so for their surgeon on a local level. We keep asking ourselves, ''Why are we not reporting granular data for all surgeries and procedures on a national level?'' Among many benefits of such an approach would be a way to help surgeons monitor their skills on an individual level in a standardized rather than self-reported way. On a larger scale, the scientific community and society as a whole will have a better understanding of diseases and treatments for the allocation of resources.
One of the main reasons why research is lacking in very common conditions that affect women such as fibroids and endometriosis affecting millions of women is because it is vastly underfunded by the NIH. 61 A popular joke on social media to reflect on this notion is: ''If men were suffering 10 days out of each month with horrible pain and bleeding that prevented them from functioning, having sex and reproducing, this a national emergency would have been declared long ago and we would have a cure for fibroids.'' While we

Direct restorative remedy #3: mandate an increase in research funding
Demand a complete overhaul in outcomes research. Acknowledge and specify the extent to which we lack the resources to do so. Expose weaknesses, lack of nuance, and gaps in current research infrastructure that prevent delivery of studies meaningful to patients and clinicians. State what it would take to create and maintain outcomes research infrastructure on national, regional, local, and institutional levels.
Failure to address fertility, menopause and sexual function, risk of malignancy, and the need for comprehensive gynecologic and medical preprocedure evaluation Fertility. The concern for patients desiring future fertility is that the direct ischemic insult to the uterus and ovaries from embolization could increase the risk of ovarian failure, decrease ovarian reserve, and impair uterine implantation. If blood flow from ovarian arteries to fibroids is noted postprocedure, ovarian blood supply is embolized due to the concern that collateral blood supply would increase failure risk. 62 Literature to inform patients about post-UFE conception rates is limited. 63 A recent metanalysis approximated fertility rates after UFE as 29% 64 and 38%, 63 which are lower than the assumed rates for the age groups reported. The only RCT to date is a study by Mara et al. published over a decade ago, which sought to compare outcomes of UFE versus myomectomy in women desiring to conceive. 30 In this trial, UFE patients had significantly lower rates of pregnancy than those in the myomectomy group (50% vs. 78%), and the relative risk of infertility after UFE was more than twice of those who underwent a myomectomy (RR = 2.22; 95% CI 1.11-4.44). Although small, the majority of myomectomies were laparoscopic, which again supports the evolution of risk and benefit calculations in the early era of MIGS.
One of the critiques of the study design is that during the follow-up, patients had a secondary procedure (myomectomy) performed in approximately a third of UFE patients per study protocol in cases where fibroids did not shrink after UFE or if they were larger than 5 cm. As a result, more patients in the UFE arm ended up with a myomectomy during follow-up, which potentially lowered their fertility rate. Based on this one study, the Cochrane review in 2014, authors warned that those findings should be interpreted with caution. 65 It is unlikely that another randomized trial looking at fertility outcomes after UFE versus myomectomy would be possible shortly.
Equally important is addressing contraceptive management after UFE for those patients who may not wish to conceive. Data are limited regarding outcomes in women who were either ambivalent about childbearing or those who ended up with unplanned pregnancies that they decided to continue. There are reports of higher miscarriage rates in the UFE pregnancies (35.2% vs. 16.5%, OR 2.8 with 95% CI 2.0-3.8). 66 No recent work has been done to further clarify higher risks of abnormal placentation, preterm labor, postpartum hemorrhage, and cesarean delivery. [66][67][68] Is embolized uterine tissue biologically different from nonembolized? What is the ischemic effect of embolization on myometrium in women who get spontaneously pregnant or those who undergo ART? We do not have clear answers.
Furthermore, there is limited published information regarding the role of contraceptive counseling or referral for such counseling during a consultation with an interventional radiologist, which is paramount for those undergoing UFE and not desiring future fertility.
Premature menopause and sexual function. Women facing hysterectomies commonly have concerns with their sexual function. The risk of an earlier onset of menopause thus becomes a common topic of discussion at the time of decision for surgery. In the evaluation of post-UFE amenorrhea along with Anti-Mullerian Hormone, follicle-stimulating hormone, and antral follicle count, early studies have shown ovarian failure rates that ranged from 6% to 14%. [67][68][69][70] Decrease in ovarian reserve after UFE is age dependent with older women experiencing greater decline and younger populations experiencing more transient changes, comparable with the effect of surgery. 71,72 How clinically meaningful this risk of loss of ovarian reserve in younger women trying to conceive is not known. While concerns about the impact of hysterectomy on ovarian function have been raised over the last decade, evidence from several randomized control trials showed that hysterectomy results in comparable rates of ovarian failure, and women closer to menopause are at higher risk. 73,74 Little is known about sexual function after UFE. A 2017 prospective descriptive study noted effects similar to that described after hysterectomy: as symptoms are treated, sexual function improves. 75 In comparison, this has been extensively looked at for patients having hysterectomies; from the patient's perspective, a hysterectomy seems similar to a more ''invasive'' procedure that takes the fertility symbol (the womb) away from them and as a result, patients might think that UFE would be less damaging to their sex lives although no literature exists to the best of our knowledge on this topic about UFE. 76 Aside from this specific patient concern, several studies have shown that sexual function actually improves after a hysterectomy. [77][78][79][80] Malignancy. Another concern at the time of UFE is unrecognized cancer risk and missing occult cancer (cervical, endometrial, and uterine), despite standardof-care preoperative workup and especially if a patient has not been evaluated or referred to a gynecologist before UFE. Reports of cancer cases after UFE 81-90 emphasize the need for preprocedure counseling regarding occult malignancy, particularly for women at higher risk for gynecologic cancer.
In 2014, the Society of Interventional Radiology (SIR) published quality improvement guidelines for UFE and highlighted that interventional radiologists should counsel patients about ''the possibility of a missed diagnosis of cancer and a delay in definitive management,'' referring to the American Association of Gynecologic Laparoscopists and American College of Obstetricians and Gynecologists (ACOG) statements from that year to quote leiomyosarcoma risk. 90 Studies have estimated gynecologic cancer incidence after UFE to be 1 in 497 women in 3 years, which varied based on age. 46,88,89,91 We do know what actual compliance with SIR's guidelines is in clinical practice in their IR community. Meanwhile, the controversy of incidentally morcellating leiomyosarcoma or having other cancer or premalignant conditions at the time of hysterectomy in 2014 had a profound effect on an entire surgical community. 86,87 Unfortunately, media attention was one-sided highlighting the risk of undiagnosed cancer during surgery, while some advertisements for UFE continue to call it an ''alternative to morcellation,'' suggesting that embolizing an Leiomyosarcoma without a tissue diagnosis would be a better option.
Another factor that needs to be added to the risk calculation is ovarian cancer risk reduction with opportunistic salpingectomy during surgery and evolving understanding of the role of oophorectomy at the time of hysterectomy. 92 Preoperative evaluation. The ACOG recommends that patients undergo a consultation with a gynecologist familiar with UFE to perform a thorough preoperative evaluation and counseling. 93 Such a statement underscores the importance of ''gynecology clearance'' for UFE. This should include thorough counseling on options for fibroid treatment in addition to ensuring cervical cancer screening is up-to-date and endometrial biopsy is completed if indicated.
Apart from gynecology consultation, there are no recommendations for any further medical clearance for UFE. Given similar rates of complications between UFE and minimally invasive gynecologic procedures, it only seems logical that patients should be medically optimized before UFE similar to the ''medical clearance'' that is obtained before surgery.

Direct restorative remedy #4
Bring to the forefront of clinical and research discourse less frequently addressed concerns with fertility, menopause and sexual function, risk of malignancy, and pre-operative assessment.
Reimbursement does not reflect the value of work Economics of UFE. Uterine leiomyomas affect up to 70-80% of women before the age of 50. 94 Given the lack of effective medical therapies, *200,000 hysterectomies and 30,000 myomectomies are performed annually in the United States, making fibroid surgery one of the most commonly performed major surgeries. [95][96][97] These numbers represent a significant market share available to any entity that wants to capitalize on treatments, from pharma and medical device companies to hospitals and private practitioners. This incentivized introduction of several nonsurgical uterine-spearing procedural alternatives over the last few decades. While no accurate tracking systems exist for reporting UFE incidence, most recent estimates noted over 25,000 UFE procedures performed annually worldwide and about 14,000 in the United States. 18,62,98,99 Relative to surgery, UFE is performed in a much small percentage of women (based on the above estimates, about 5%).
Notably, while the overall long-term cost-effectiveness of UFE is not favorable when compared with the surgery, 32 total reimbursement in outpatient private practice settings is well-reimbursed and is profitable. 100,101 As a result, UFE providers in a private setting often engage in effective direct marketing to patients. 102 Gynecologic surgery and hospital-based work (where most radiologists who perform UFE are based in academic centers) remain underpaid and cover more uninsured and underinsured patients compared with ''private centers,'' which can collect from well-reimbursing commercial insurance. In our urban academic center, for example, such centers (which call themselves ''fibroid centers'') are growing rapidly. This is one of the downstream effects of discrimination against MIGS surgeons outlined in a recent commentary; the value of surgical care delivered to women is ignored by systemic sexism, complex, and as result, patients and surgeons suffer. 103 Procedural alternatives. Given the financial success of UFE, several other interventional alternatives have been recently introduced to the U.S. market: Magnetic resonance-guided focused ultrasound (MRgFUS, ExA-blateÔ) 104 and Ultrasound-guided RFA (AcessaÔ and SonataÔ). [105][106][107] While promising alternatives due to their more focal nature, uptake of these in clinical practice has been slow due to barriers in reimbursement, and comparative effectiveness trials remain limited. 108 Direct restorative remedy #5 Change the payment system from fee-for-service to valuebased and create financial insensitive for individuals, instituions and health sytems that will prioritize delivery of high-quality care to women.
Lack of coordination between specialties and services Patient selection. While most entities agree on absolute contraindications such as pregnancy, active infection, or suspected cancer, relative contraindications are still unclear and there is little guidance on how to select an ''ideal candidate.'' Even in uncomplicated cases, counseling becomes complex and nuanced with limited data to rely on, let alone for more complex patients with large uterine volumes and those desiring to preserve fertility. 90 Unfortunately, there is little interprofessional collaboration between radiologists and gynecologists in academia. Each specialty typically writes its articles and reads its journals. Historically, the limited guidelines surrounding UFE have typically been generated by the Obstetrics and Gynecology and IR groups separately, without comprehensive collaborative efforts.
For example, a working group of interventional radiologists recently came up with a metric system of thresholds for outcomes and complications with hopes of helping clinicians implement UFE services 90,109 ; however, this work did not include coordination of care and details of how high-quality programs should be implemented. While consensus is emerging that patient selection is a key factor, 34 no joint coherent guidelines exist to reconcile the viewpoints of both gynecologists and radiologists and emphasize multispecialty care.
Create fibroid centers of excellence. The lack of coordinated delivery of care has been addressed in a few publications, but they are not reaching high visibility in either specialty. When patients are only seen by interventional radiologists, coordination with gynecologists is seen by some as nonrevenue generating, timeconsuming, and burdensome. 110 A study by Nakhaei et al. highlighted how the coordination of care between gynecologists and interventional radiologists may be critical to optimizing patient selection and outcomes. 110 Tan et al. described a comprehensive fibroid center at their institution and resulting in improvements in individualized care. 111 While there is a multitude of publications on multidisciplinary care programs in other domains, there is a lack of publications on multidisciplinary care for fibroids. 112,113 Given the lack of centralized guidance and a clear need to take care of a large number of patients with fibroids, institutions on a local level are taking matters into their own hands and creating multispecialty fibroid centers to address this problem (pers. comm.). 114,115 On a positive note, inspiring and encouraging initiatives are carried out from the ''ground up'' by clinicians and vary in their extent and scale. A general implementation plan can include suggested steps outlined in Table 1. While this list is extensive, it should be adopted for each specific institution. For example, a hospital with limited resources might be able to launch a UFE clinic by allowing joint clinic panels between gynecologists and interventional radiologists to occur several times a month while using existing support staff and utilizing simple and free ways to disseminate information.
On the contrary, an institution with more resources might choose to finance the large-scale building of a full-service line with additional salary lines, staff, and a marketing campaign. It is important to note that in either case, financial success should be defined by desired outcomes rather than itemized collections by each service line. In the best-case scenario, if you get a gynecologic surgeon and an interventional radiologist to review a patient's case before seeing them, and then counsel the patient together in the same room at the same time, the patient is more likely to get a full picture rather than a disjointed one.
While we realize that the major challenge of choosing the appropriate treatment for symptomatic fibroids is a highly variable presentation for each patient and no suitable formula or calculator to fit them into, we nevertheless propose one way to approach patient selection in Table 2 based on the best available evidence. For example, a morbidly obese 45-year-old woman who is done with childbearing with a 12week-sized fibroid uterus with mostly intramural myomas with a history of two prior laparotomies and who is concerned with surgical risk can consider UFE as a viable option.
On the contrary, a 38-year-old patient who is attempting pregnancy with a 14-week-sized uterus and a 5-cm intramural myoma with a submucosal component should be counseled that UFE is a poor choice for her given the impact on her fertility and high failure rate. Likewise, a 48-year-old woman with a 28-week-sized fibroid uterus and bothersome bulk symptoms should be told that UFE is not going to provide her with adequate symptomatic relief.

Direct restorative remedy #6
Define meaningful patient selection criteria and create collaborative patient-centered service lines to deliver care.
Proposed Solutions: What Needs to Happen to Deliver High-Quality Medical Care While the solutions proposed above are a starting point for discourse, we feel that it is important to voice our concern about the delivery of medical care in our country on the large scale. Without a complete overhaul, any efforts at improvement are not likely to make a difference for most patients, and our ''solutions'' will end up being isolated and short-term measures even if they are successfully implemented. While this proposition seems radical and unrealistic, many social justice movements were also considered to be historical and this movement to revolutionize American health care is getting more and more momentum. 116,117 While Victor Montori argues in his book ''Why We Revolt'' that health care needs to be redesigned to provide ''careful and kind care,'' we believe that a doctorpatient alliance and advocacy movement needs to take control of all health care to do the right thing for each patient and deliver meaningful improvements.
On a larger scale, the idea of industrial health care in which health care entities need to make money to survive is considered not only wrong but also not viable from a business standpoint. Domains such as health care, education, childcare, eldercare, and other services such as national parks are viewed as a public good, not an opportunity to make money. It is viewed as a basic infrastructure that society needs to function. Health care is a cost of doing business, not a way to make a profit. Companies see the health of their workforce as a necessity to stay completive and as a result view health care expenses as a ''sunk cost,'' just like the rent they pay for their office space.
One of the factors is the fee-for-service payment model. If you get paid regardless, why bother with real outcome research? Lack of prospective data collection to answer simple clinical questions? Who would pay for this? Data collection and monitoring of outcomes for surgery and UFE on a national level? Lack of allocation of money to delivery of gynecologic care while other areas end up with getting resources because of politics? None of these deeper questions can be addressed without a complete overhaul. Of note, several attempts to implement change within the existing system, the most visible of which was a Buffett-Bezos-Dimon company, Heaven Healthcare, headed by physician-activist, Atul Gawande, as its CEO, 118 have failed miserably given the premise of needing to redesign the system rather than trying to work within the existing structure. 119 This feeling of powerlessness to make meaningful improvements to the care our patients receive is how many, if not most, clinicians feel about their day-to-day professional lives and greatly contributes to moral injury and burnout. Surgeons quit operating, and MIGS positions are unfilled in many hospitals. In the last 5 years, six fellowship-trained gynecologic surgeons stopped operating in a 5-mile radius in New York City alone (pers. comm.). We think that all of us need to speak out and expose injustices that prevent us from doing our best for our patients. The first step would be to expose the problem while working on finding ways to do it right.

Conclusions
In this article, we used fibroid care as an example to dissect factors and drivers of what goes on ''behind the scenes'' and results in failure of delivery of standard of care. We described the historical background of the barriers clinicians face in the trenches, such as the sequelae of misogyny from underfunding of research in women's health to lack of integrated approach, and poor communication. We also addressed economic disincentives to do the right thing, and we discussed potential remedies to those problems. We hope patients, clinicians, advocates, and stakeholders can benefit from this discussion and feel validated in their struggle to do their best in caring for patients.

Funding Information
No funding was received for this article.